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REGN15160

Phase 1

Undisclosed | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Trials Updated: Feb 23, 2023

REGN15160 target and mechanism

ModalitySmall molecule

Also known as REGN15160 (IV)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

REGN15160 clinical trials

REGN15160 · 1 trial · 1 indication

Phase 1 1
NCT05293678Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19Healthy
COMPLETED104 Analytics
PHASE1COMPLETED
Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence and severity of all treatment emergent adverse events (TEAEs)
Through Day 169
Occurrence and severity of all serious adverse events (SAEs)
Through Day 169

Secondary Endpoints

Concentrations of REGN15160 in serum
Through Day 169
Incidence and titer of anti-drug antibodies (ADA) to REGN15160
Through Day 169
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lower IV DoseEXPERIMENTALRandomized 3:1
Mid IV Dose 1EXPERIMENTALRandomized 3:1
Mid IV Dose 2EXPERIMENTALRandomized 3:1
Higher IV DoseEXPERIMENTALRandomized 3:1
Lower SC DoseEXPERIMENTALRandomized 3:1
Mid SC DoseEXPERIMENTALRandomized 3:1
Higher SC DoseEXPERIMENTALRandomized 3:1

Interventions

NameTypeDescription
REGN15160 (IV)DRUGAdministered in single intravenous (IV) dose
Matching Placebo (IV)DRUGAdministered in single IV dose
REGN15160 (SC)DRUGAdministered in single subcutaneous (SC) dose
Matching Placebo (SC)DRUGAdministered in single SC dose
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: 1. Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization using a local reverse transcription polymerase chain reaction (RT-PCR) test or other molecular diagnostic assay and sample collection following assay standards 2. Has received c...

Countries:Belgium
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Frequently asked questions about REGN15160

What is REGN15160?

REGN15160 is an investigational small molecule developed by Regeneron Pharmaceuticals, Inc. It has been studied in a Phase 1 clinical trial in adult healthy volunteers. The specific disease indication for REGN15160 has not been publicly disclosed.

Who makes REGN15160?

REGN15160 is being developed by Regeneron Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker REGN. Regeneron sponsored the Phase 1 trial of REGN15160 conducted in Belgium.

What phase is REGN15160 in?

REGN15160 is in Phase 1 development. One Phase 1 trial of REGN15160 has been completed, and no active trials are currently listed. The study enrolled 104 participants and was randomized, double-blind, and controlled.

What clinical trials is REGN15160 in?

REGN15160 has been evaluated in one completed Phase 1 trial, NCT05293678, titled Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19. The trial enrolled 104 healthy adult volunteers aged 18 years and older in Belgium.

Is REGN15160 the same as REGN15160 (IV)?

Yes, REGN15160 (IV) refers to the same investigational asset as REGN15160. The parenthetical IV designation distinguishes the intravenous formulation. Both names refer to the small molecule developed by Regeneron Pharmaceuticals, Inc. that was studied in the completed Phase 1 trial NCT05293678.